Use of Virtual Reality to Improve Pain and Anxiety Management of Children During Dupilumab Injection for Atopic Dermatitis (VR-DERMA)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this within-subject randomized study is to examine the efficacy of a VR immersive game for pain and anxiety management of children during the subcutaneous injection of dupilumab for moderate to severe atopic dermatitis. We will recruit children from 6 to 17 years. The main research question is: 1. Does VR immersive game will generate less anxiety and pain than standard procedures, for children receiving dupilumab injection for moderate to severe atopic dermatitis? 2. Does the occurence of side effects is similar between both study groups? Participants will be randomized according to either sequences: VR-Standard care or Standard care-VR. During the VR sequence, participants will be playing the VR immersive game during the injection. During the Standard care sequence participants will not benefit from any pain management but passive distraction tools will be offered (and documented) to children. The investigators will take measures of pain and anxiety, using validated scales, before and after the procedures at each sequence.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• between the ages of 6 to 17 years old,

• suffering from moderate to severe atopic dermatitis and receiving or about to start subcutaneous injections of dupilumab,

• in the presence of a consenting parent who can understand, read, and write either French or English.

Locations
Other Locations
Canada
CHU Sainte-Justine
RECRUITING
Montreal
St. Justine's Hospital
RECRUITING
Montreal
Contact Information
Primary
Sylvie Le May, PhD
sylvie.lemay@umontreal.ca
5143454931
Time Frame
Start Date: 2024-05-16
Estimated Completion Date: 2028-01
Participants
Target number of participants: 98
Treatments
Experimental: Virtual Reality Distraction
The child will play with the VR device for five minutes prior to the subcutaneous injection.
Active_comparator: Standard Treatment
Standard care consisting of injecting dupilumab subcutaneously without any distractive measure, with the child having full knowledge of the intervention
Related Therapeutic Areas
Sponsors
Leads: St. Justine's Hospital

This content was sourced from clinicaltrials.gov

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